Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MATADOR, BOOG 2005-02, CKTO 2004-04

Study hypothesis

Current study hypothesis as of 29/04/2013:To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel-containing chemotherapy.

Previous study hypothesis until 29/04/2013:With microarray analysis of primary breast cancers of patients who participate in this study one can identify gene expression profiles that can predict a disease-free survival advantage for either dose dense therapy, docetaxel, and/or 6 versus 4 courses of chemotherapy.

Please note that as of 29/04/2013, the following changes were made to the trial record:1. The anticipated end date for this trial was updated from 30/09/2008 to 19/11/20122. The target number of participants was updated from 1200 to 600

Ethics approval

Netherlands Cancer Institute, 15th March 2004, ref: EV04-87

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Breast cancer

Intervention

Current interventions as of 29/04/2013:Randomization to one of the treatment arms (6 cycles TAC or AC dd)

ACdd:doxorubicin 60 mg/m2 i.v. bolus and cyclophosphamide 600 mg/m2 i.v. bolus on day 1 every 2 weeks.TAC:Doxorubicin 50 mg/m² as an i.v. bolus on day 1, followed by cyclophosphamide 500 mg/m2 as i.v. bolus and, after 1 hour, docetaxel 75 mg/m² as 1 hour i.v. infusion on day 1 every 3 weeks.Both Arms:- prophylactic pegfilgrastim 6 mg s.c. given 1 day after completion of administration of each chemotherapy cycle;- Radiotherapy, if indicated;- Endocrine treatment for at least 5 years, (according to the most recent Dutch national guidelines)starting 1 to 6 weeks after radiotherapy or 3 to 6 weeks after chemotherapy for patients with positive estrogen and/or progesterone receptors.

HER2 positive patientsFor HER2 positive patients we recommend to treat these patients outside the context of this study. Only in case of an increased risk of cardiotoxicity, the HERA study schedule is an alternative, in which case patients could participate in the MATADOR study.Both Arms:For HER2 positive patients with increased risk of cardiotoxicity, who are going to receive trastuzumab according to the schedule of the HERA study, trastuzumab should be given for 52 weeks, and should start within 7 weeks from day 1 of the last chemotherapy cycle or within 6 weeks from the end of adjuvant radiotherapy, whichever is last.

Previous interventions until 29/04/2013:2 randomizations:1. To one of the treatment arms (TAC or AC dd)2. To 4 or 6 courses of chemotherapy (second randomization only open for patients with 1-3 positive axillary lymph nodes)

Both Arms:1. Prophylactic pegfilgrastim 6 mg sc given 1 day after completion of administration of each chemotherapy cycle2. Radiotherapy, if indicated3. Endocrine treatment for 5 years, starting 1 to 6 weeks after radiotherapy or 3 to 6 weeks after chemotherapy for patients with positive estrogen and/or progesterone receptors.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Current primary outcomes as of 29/04/2013:To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxelcontaining chemotherapy.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant exclusion criteria

Current exclusion criteria as of 29/04/2013:1. Prior systemic anticancer therapy for any cancer (immunotherapy, hormonal therapy, chemotherapy)2. Prior radiation therapy for breast cancer3. HER2 positive breast cancer (except for patients who are going to be treated according to HERA study (1c) 4. Pregnant, or lactating patients5. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria6. Other serious illness or medical condition: 6.1. Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias6.2. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent6.3. Active uncontrolled infection7. Past history of invasive breast cancer or past or current history of neoplasm other than breast carcinoma, except for:7.1. Curatively treated non-melanoma skin cancer7.2. In situ carcinoma of the cervix7.3. Ipsilateral ductal carcinoma in-situ (DCIS) of the breast7.4. Lobular carcinoma in-situ (LCIS) of the breast8. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry9. Male patients

Previous exclusion criteria until 29/04/2013:1. Prior systemic anticancer therapy for any cancer (immunotherapy, hormonal therapy, chemotherapy)2. Prior radiation therapy for breast cancer3. Pregnant, or lactating patients4. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI criteria5. Other serious illness or medical condition:5.1 Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias5.2 A history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent5.3 Active uncontrolled infection6. Past or current history of neoplasm other than breast carcinoma, except for:6.1 Curatively treated non-melanoma skin cancer6.2 In situ carcinoma of the cervix, cipsilateral ductal carcinoma in-situ (DCIS) of the breast, 6.3 Llobular carcinoma in-situ (LCIS) of the breast7. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.8. Male patients